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510(k) Data Aggregation
K Number
K991380Device Name
OIL FOR TISSUE CULTURE
Manufacturer
ADVANCED REPRODUCTIVE TECHNOLOGIES
Date Cleared
2000-04-19
(364 days)
Product Code
MQL
Regulation Number
884.6180Why did this record match?
Applicant Name (Manufacturer) :
ADVANCED REPRODUCTIVE TECHNOLOGIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Oil for Tissue Culture is used in covering tissue culture in in-vitro fertilization, embryo culture and micromanipulative procedures such as ICSI and assisted hatching.
Device Description
Not Found
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K Number
K991395Device Name
QUINN'S HTF MEDIUM, QUINN'S HTF MEDIUM WITH HEPES, QUINN'S BASAL XI HTF MEDIUM, QUINN'S D3+ HTF MEDIUM
Manufacturer
ADVANCED REPRODUCTIVE TECHNOLOGIES
Date Cleared
2000-02-15
(300 days)
Product Code
MQL
Regulation Number
884.6180Why did this record match?
Applicant Name (Manufacturer) :
ADVANCED REPRODUCTIVE TECHNOLOGIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Media for Embryo Preparation products that are used for assisted reproduction procedures. These media come in direct physical contact with human gametes or embryos for the purposes of preparation, maintenance, transfer or storage.
Quinn's® HTF Medium was developed for in vitro fertilization and procedures involving the culture of early cleavage stage mammalian embryos.
Quinn's® HTF Medium with HEPES was developed for in vitro procedures involving manipulations of gametes and embryos not requiring the use of a CO2 incubator. Such procedures include oocyte recovery, gamete washing, micromanipulation, embryo transfer and cryopreservation.
Quinn's® Basal XI HTF Medium was developed for in vitro procedures involving the culture of early cleavage stage mammalian embryos. This is the medium for culture of embryos from Day 1 through to Day 3.
Quinn's® D3+ Medium was developed for in vitro procedures involving the culture of early cleavage stage mammalian embryos. This is the medium for culture of embryos after Day 3 of development.
Device Description
Media for Embryo Preparation products that are used for assisted reproduction procedures. These media come in direct physical contact with human gametes or embryos for the purposes of preparation, maintenance, transfer or storage.
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K Number
K991392Device Name
HUMAN SERUM ALBUMIN
Manufacturer
ADVANCED REPRODUCTIVE TECHNOLOGIES
Date Cleared
2000-02-07
(292 days)
Product Code
MQL
Regulation Number
884.6180Why did this record match?
Applicant Name (Manufacturer) :
ADVANCED REPRODUCTIVE TECHNOLOGIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Human Serum Albumin is a macromolecular supplement used in media for IVF, ART, GIFT, ICSI, embryo culture, embryo transfer, cryopreservation and sperm washing for IUI.
Device Description
Not Found
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K Number
K991379Device Name
QUINN'S SPERM WASHING MEDIUM
Manufacturer
ADVANCED REPRODUCTIVE TECHNOLOGIES
Date Cleared
2000-02-02
(287 days)
Product Code
MQL
Regulation Number
884.6180Why did this record match?
Applicant Name (Manufacturer) :
ADVANCED REPRODUCTIVE TECHNOLOGIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Quinn's® Sperm Washing Medium is for in vitro procedures involving sperm washing and incubation.
Device Description
Quinn's® Sperm Washing Medium
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K Number
K991391Device Name
PVP, POLYVINYLPYRROLIDONE 10% (W/V) IN HEPES-HTF
Manufacturer
ADVANCED REPRODUCTIVE TECHNOLOGIES
Date Cleared
2000-01-10
(264 days)
Product Code
MQL
Regulation Number
884.6180Why did this record match?
Applicant Name (Manufacturer) :
ADVANCED REPRODUCTIVE TECHNOLOGIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
PVP is used for the intracytoplasmic sperm injection (ICSI) procedure to decrease the motility of spermatozoa, prevent their sticking to the injection pipette during the procedure and to give more control over the flow of fluid in the ICSI needle.
Device Description
PVP, 10%, (W/V) in Hepes-HTF (Tissue Culture Media)
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